K Number

Device Name

Surgical Gown (40083)

Manufacturer

Ammex-Weida (Hubei) Health and Safety Products Co., Ltd

Date Cleared

2024-02-01

(126 days)

Product Code

FYA

Regulation Number

878.4040

Intended Use

Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requrements of AAMI Level 3 barrier protection for a surgical gown per ANSI/A AMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices, provided sterile.

Device Description

The proposed device Surgical Gown is model 40083, its body, sleeve and belt are made of SSMMS non-woven material, and cuff is made of cotton. The proposed device is available in XS, S, M, L, XL, 2XL, 3XL sizes. This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012. The proposed devices are disposable medical devices and provided in sterile and blue color.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K231510

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a surgical gown, and the summary focuses on material properties and barrier performance, with no mention of AI or ML.

Therapeutic

No.
The device (surgical gown) is intended to protect patients and personnel from the transfer of microorganisms, body fluids, and particulate material, not to treat or cure a disease or medical condition.

Diagnostic

The device is a surgical gown, which is intended to protect operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material. It does not diagnose any condition or disease.

SaMD (Software as a Medical Device)

The device described is a physical surgical gown made of non-woven material and cotton, with performance studies focused on material properties and barrier protection. There is no mention of software components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the surgical gown is for protecting surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic one.
Device Description: The description focuses on the materials, construction, and barrier performance of the gown. There is no mention of any components or functions related to testing samples from the human body.
Performance Studies and Metrics: The performance studies and metrics evaluate the physical properties and barrier performance of the gown (strength, tear resistance, lint generation, water resistance, sterilization residuals, biocompatibility). These are relevant to a protective garment, not a diagnostic test.
No mention of analyzing samples: IVD devices are designed to analyze samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This document does not describe any such function.

Therefore, the surgical gown described is a medical device intended for protection and barrier function, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

FYA

Device Description

The proposed devices are disposable medical devices and provided in sterile and blue color.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

operating room personnel during surgical procedures

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The subject surgical gown was assessed for performance using the following Standards and Test Methods. The test results demonstrated that the proposed device met its acceptance criteria or testing endpoints.

Study Type: Non-clinical tests
Sample size:
Seam strength: 30 samples
Breaking strength: 30 samples
Tear strength: 30 samples
Lint and other generation in the dry state: 6 samples
Key Results: All tests passed the acceptance criteria, demonstrating the safety and effectiveness of the device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Seam strength: 68.46 N (Average result from 30 samples)
Breaking strength: MD: 120.61N, CD: 88.19N (Average result from 30 samples)
Tear strength: MD: 60.03N, CD: 39.78N (Average result from 30 samples)
Lint and other generation in the dry state: 1.9 (Average result from 6 samples)
Flammability: Class I
Water Penetration Resistance: =50 cm
EO and ECH sterilization residual: EO

Regulation Number and Section

§ 878.4040 Surgical apparel.

(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 1, 2024

Ammex-Weida (Hubei) Health and Safety Products Co., Ltd % Jarvis Wu Senior Consultant Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China

Re: K233183

Trade/Device Name: Surgical Gown (40083) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: December 29, 2023 Received: December 29, 2023

Dear Jarvis Wu:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bifeng Qian -S

Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K233183

Device Name

Surgical Gown (40083)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary K233183

Document prepared date: 2024/1/30

A. Applicant:

Name: Ammex-Weida (Hubei) Health and Safety Products Co., Ltd Address: Southern Industrial Zone (Xinlirenkou), Xiantao, Hubei China, 433011 Contact Person: Melody Wang Tel: +86 13476816925 Mail: office@hborient.com

Submission Correspondent: Primary contact: Mr. Jarvis Wu Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122. China Tel: +86-21-58817802 Email: jiawei.wu@sungoglobal.com Secondary contact: Mr. Raymond Luo 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050

Email: zxfda@sungoglobal.com

B. Device:

Trade Name: Surgical Gown Common Name: Surgical Gown Model(s): 40083

Regulatory Information Classification Name: Gown. Surgical Classification: Class II Product code: FYA Regulation Number: 21 CFR 878.4040 Review Panel: Surgical Apparel

C. Predicate device:

K231510 Surgical Gown XIANTAO ZHIBO NON-WOVEN PRODUCTS CO.,LTD

D. Intended use /Indications for Use:

Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices, provided sterile.

E. Device Description:

The proposed devices are disposable medical devices and provided in sterile and blue color.

Table 1 General Comparison
Device	Proposed Device	Predicate Device	Remark
Manufacturer	Ammex-Weida (Hubei) Health and
Safety Products Co., Ltd	XIANTAO ZHIBO NON-WOVEN
PRODUCTS CO.,LTD.	-
510K number	K233183	K231510	-
Product
Name	Surgical Gown	Surgical Gown	Same
Classification	Class II Device, FYA (21
CFR878.4040)	Class II Device, FYA
(21CFR878.4040)	Same
Intended use
/Indications
for Use	Surgical Gowns are intended to be
worn by operating room personnel
during surgical procedures to protect
the surgical patient and operating
room personnel from the transfer of
microorganisms, body fluids and
particulate material. This surgical
gown meets the requirements of
AAMI Level 3 barrier protection for
a surgical gown per ANSI/AAMI
PB70:2012 Liquid barrier
performance and classification of
protective apparel and drapes
intended for use in health care
facilities (AAMI PB70). The
Surgical Gowns are single use,
disposable medical devices,
provided sterile.	Surgical Gown is intended to be
worn by room personnel during
surgical procedures or other invasive
tests to protect both the surgical
patient and operating room
personnel from the transfer of
microorganisms, body fluids and
particulate material. This is single
use, disposable device, provided
sterile.
Per ANSI/AAMI PB70:2012 Liquid
barrier performance and
classification of protective apparel
and drapes intended for use in health
care facilities, the Surgical Gown
met the requirements for Level 3
classification.	Same
Style	Non-reinforced	Non-reinforced	Same
Use	Single Use; Disposable	Single Use; Disposable	Same
Color	Blue	Blue	Same
Labeling	Conform with 21CFR Part 801	Conform with 21CFR Part 801	Same
Item	Proposed Device(K233183)	Predicate Device(K231510)	Remark
Size	XS, S, M, L, XL, 2XL, 3XL	S, M, L, XL, XXL, XXXL	Different.
resolved by
performance
testing
Weight per
square(g)	45 g/m2	50 g/m2	Different.
No affect on
safety or
efficacy
Hydrostatic
Pressure(cm)
AATCC-127	>50 cm	>50 cm	Same
Water impact
AATCC-42	≤1.0 g	≤1.0 g	Same
Breaking
strength	MD: 120.61N
CD: 88.19N	MD: 144.87N
CD: 88.89N	Similar
Tearing
strength	MD: 60.03N
CD: 39.78N	MD: 69.61N
CD: 32.25N	Similar
Seam
Strength	>30N	>30N	Same
Flammability	Class I	Class I	Same
EO residue	EO ≤ 4mg/d
ECH ≤ 9mg/d	EO ≤ 4mg/d
ECH ≤ 9mg/d	Same
Shelf life	3 years	3 years	Same
Barrier
protection level	Level 3 per AAMI PB 70	Level 3 per AAMI PB 70	Same
Material	SSMMS non-woven, Cotton,
and Nylon + polyester	SMMS non-woven, Cotton, and Nylon	Different
Biocompatibility	Under the conditions of the study, the device extract was not cytotoxic.
Under the conditions of the study, the non-polar and polar device
extracts were not found to be an irritant.
Under conditions of the study, the non-polar and polar device
extracts were not found to be a sensitizer.		Same

F. Comparison with predicate device Table 1 General Comparison

Table 2 Safety and Performance Comparison

Analysis

The weight per square (g) ,size and material are slightly different from those of the predicate device. The proposed device has been tested according to ASTM D5587-15, ASTM D5034-09 (2017) and ASTM D1683/D1683M-17(2018) respectively, and met the requirements of the standard.

Difference of the materials will not raise safe and effectiveness concerns. The biocompatibility and performance tests have been conducted to verify the safety and effectiveness of the material. Under the conditions of each study, the subject surgical gowns are non-cytotoxic, non-sensitizing and negligibly irritating per ISO-10993 and have met the requirements of ANSI/AAMI PB70:2012 Liquid Barrier

Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities for AAMI Level 3 surgical gowns.

G. Summary of Non-Clinical Tests

Test Item	Test standard	Acceptance Criteria
Seam strength
ASTM D1683M-
17 Standard Test
Method for
Failure in Sewn
Seams of Woven
Fabrics.	The test was performed
In accordance with
ASTM D1683M-17
Standard. Test Method
for Seam Strength of
Textile Fabrics (Grab
Test) to evaluate Failure
in Sewn Seams of the test
sample.	≥30N(7lbf)
per standard
F2407-20 for level 3	PASS
68.46 N
(Average result from 30
samples)
Breaking
strength
ASTM D5034-09
(2017)
Standard Test
Method for
Breaking Strength
and Elongation of
Textile Fabrics
(Grab Test)	The test was performed
In accordance with
D5034-09 (2017) .
Standard. Test Method
for Breaking Strength
and Elongation of Textile
Fabrics (Grab Test) to
evaluate the breaking
strength of the test
sample.	≥30N(7lbf)
per standard
F2407-20 for level 3	PASS
MD: 120.61N
CD: 88.19N
(Average result from 30
samples)
Tear strength(N)
ASTM D5587-15,
Standard Test
Method for
Tearing Strength
of Fabrics by
Trapezoid
Procedure	The test was performed
in accordance with
ASTM D5587:
2015(2019) Standard
Test Method for Tearing
Strength of Fabrics by
Trapezoid Procedure to
evaluate the tearing
strength of the test
sample.	≥20N	PASS
MD: 60.03N
CD: 39.78N
(Average result from 30
samples)
Lint and other
generation in the
dry state
ISO 9073-
10:2003(E)	The test was performed
in accordance with ISO
9073-10: 2003 Textiles-
Test Methods for
Nonwovens-Part 10: Lint
and Other Particles
Generation in the Dry
State to evaluate the
linting of the test sample.	Log10(particle count)